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Moregate/Bovine Serum Albumin - Low Fatty Acid (BSA-LF)/null/BSALF
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产品说明
BSA low fatty acid is a highly purified, lyophilized powder.  Fatty acids are removed by treatment with carbon at low pH. This product is processed to provide a minimum of 98% albumin and ≤0.1% Fatty acids.  It can be used for cell culture applications.SPECIFICATION - Bovine Serum Albumin - Low Fatty Acid (BSA-LF)ProductBovine Serum Albumin- Low Fatty AcidCatalogue No.BSALFCertificate of SuitabilityAustralia: R1-CEP 2005-191-Rev 00New Zealand: R1-CEP 2003-205-Rev 00SourceBovine plasma from healthy animals inspected ante and post mortem by New Zealand or Australian Government veterinarians and passed as fit for human consumptionCollection/Processing MethodCohn Fraction V Purified by heat shock treatment with charcoal treatment and diafiltrarion.DescriptionOff white to pale green / yellow lyophilised powderStability500ml & 1000ml sterile PET & PETG "Nalgene" bottlesStorageStore in sealed containers with a desiccant under dry conditions between 2 - 8°CAnalysisMethodRangepHpH meter6.5 - 7.2AlbuminGel Electrophoresis≥ 98%ProteinLECO CF003.1 (dry basis)≥ 96%Moisture ContentOven Moisture Content≤ 5.0%ChlorideCoulometric≤ 0.15%CalciumICP-OES≤ 0.05%IronICP-OES≤ 0.002%MagnesiumICP-OES≤ 0.005%Phosphorus, inorganicCoulometric≤ 0.005%PotassiumICP-OES≤ 0.015%SodiumICP-OES≤ 0.8%LeadICP-OES≤ 0.003%Ash ContentGravimetric≤ 2.5%Optical DensityAbs 405nm at 60mg/ml sol≤ 0.2Solubility60mg/ml sol.SolubleBioburdenHeterotrophic Colony count - pour plate≤ 100 CFU/gTotal Free Fatty AcidsGas Chromatography≤ 0.1%EDQMThe European Directorate for the Quality of Medicines (EDQM) has originated from the European Pharmacopoeia Secretariat which, with the addition of new responsibilities changed its name to the European Department for the Quality of Medicines (EDQM).  The EDQM sits alongside the European Medicines Agency (EMEA).Amongst other activities, the EDQM is responsible for the European Pharmacopeia and the issuing of Certificates of Suitability (CEP).Certificates of Suitability (CEP) are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them.  In the case of Fetal Bovine Serum and other Bovine Serum a CEP can be used by the manufacturers of Fetal Bovine Serum and other Bovine Serum which is intended for use in the manufacture of pharmaceutical products to demonstrate compliance with the Bovine Serum monographs of the European Pharmacopoeia and the EDQM requirements for substances concerned by TSE risk.The discovery of Bovine Spongiform Encephalopathy (BSE), which is one of a group of similar infections now referred to as Transmissible Spongiform Encephalopathies (TSEs), and it’s spread over many countries of the European Union as well as its discovery in Canada, the USA and Japan is well known. The European events provided the impetus for the Council of Europe Public Health Committee (CEPHC) to pass Resolution AP-CSP (99) 5 addressing the TSE concerns and creating a Certificate of Suitability (COS) pursuant to Directive 75/318/EEC.The granting of a CoS to a manufacturer, for a particular product, certifies that the product in question has been assessed for the level of risk of transmission of TSEs, and that the risk level is considered low enough that the product is certified as suitable for use in the manufacture of medicinal products in the European Union.The process of approval requires the manufacturer to submit a dossier that covers all relevant aspects of the collection of raw material and further processing that is performed to reach the product that is offered to end users. This dossier is detailed and covers the specific material that is collected, the collection method, process validation, testing, traceability, quality systems and an expert review.Only after this dossier has been examined and approved by two rapporteurs and, if necessary, by a panel of experts appointed by the European Directorate for the Quality of Medicines (EDQM) is the manufacturer granted a COS.   Moregate Biotech has been granted a COS for:    - Fetal Bovine Serum – Australian Origin – CEP2000-187    - Fetal Bovine Serum – New Zealand Origin – CEP2000-188    - Adult Bovine Serum - New Zealand Origin – CEP2001-093    - Adult Bovine Serum (Defibrinated) - New Zealand Origin – CEP2000-174    - Bovine Plasma – New Zealand Origin – CEP2003-199    - Bovine Serum Albumin – manufactured in Australia from New Zealand origin Bovine Plasma – CEP2003-205    - Bovine Plasma – Australian Origin - CEP 2005-192    - Bovine Serum Albumin – manufactured in Australia from Australian origin Bovine Plasma - CEP 2005-191Copies of the Certificates of Suitability are available upon requestHazards IdentificationSPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT- Not hazardous.First Aid MeasuresGet Medical attention immediately.InhalationIf inhaled, remove to fresh air. If breathing becomes difficult, call a physicianIngestionIf swallowed, give several glasses of water to drink to dilute.Skin ContactWash skin with soap and copious amounts of water.Eye ContactFlush with water for at least 15 minutes, lifting upper and lower eyelids occasionally.Procedures for Personal PrecautionExercise appropriate precautions to minimize direct contact with skin or eyes.Methods for Cleaning UpMop upVentilate area and wash spill site after material pickup is completeFire fighting MeasuresExtinguishing MediaWater spray. Carbon dioxide, dry chemical powder, or appropriate foam.Special RisksEmits toxic fumes under fire conditionsSpecial Protective Equipment for FirefightersWear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.Accidental ReleaseProcedures for Personal PrecautionExercise appropriate precautions to minimize direct contact with skin or eyes.Methods for Cleaning UpMop upVentilate area and wash spill site after material pickup is completeHandling and StorageHandlingAvoid contact with eyes, skin and clothing.StorageKeep tightly closed. Store at 2 - 8 °C.Exposure Controls / Personal Protection- Wash thoroughly after handling.- Wear dust mask- Protective gloves- Chemical safety gogglesDisposal ConsiderationsContact a licensed professional waste disposal service to dispose of this material.Transport Information- Non-hazardous for road transport- Non-hazardous for sea transport- Non-hazardous for air transportNote: The above information is believed to be correct, but shall be used as a guide only.Disclaimer: For pharmaceutical use only.BOVINE SERUM ALBUMINMoregate Bovine Serum Albumin BSA is manufactured from Bovine Plasma of Australian or New Zealand origin in a well equipped facility located in Bulimba, Australia. The manufacturing process is a modified Heat Shock method.The process includes ultrafiltration, micro filtration and freeze-drying.Trained personnel following Standard Operating Procedures perform all operations. Each batch has a Manufacturing Record, which is reviewed after batch completion.

Moregate Biotech 公司在澳大利亚的布里斯班和新西兰的汉密尔顿都建有符合GMP条件的生产设施,产品的原材料分别取自澳大利亚和新西兰。自公司成立以来,已经为各大国际制药企业和众多研究机构提供产品、原料和服务,在世界各地范围内,Moregate都赢得了良好产品声誉和客户满意度。

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